Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042226221

FEI Number

3042226221

Entity Name

PT MEDLINKET MEDICAL INDONESIA

City/State/Country

Batam Kepulauan Riau, ID

Establishment Address

Kawasan Industri Tunas Kabil Type 7-D, Desa/Kelurahan Kabil, Kec. Nongsa, Batam Kepulauan Riau 29467, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PT MEDLINKET MEDICAL INDONESIA (Owner Number: 10094007)

Owner / Operator Contact Address

Kawasan Industri Tunas Kabil Type 7-D, Desa/Kelurahan Kabil, Kec. Nongsa, Batam, ID-KR 29467, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable temperature probe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-11-23

Official Correspondent

Maolin Ye

US Agent Details

Faye Liang Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

PT MEDLINKET MEDICAL INDONESIA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16

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3029906224	Hamilton Medical AG	Domat/Ems Graubunden, CH
3011137372	Teleflex Medical LLC	Morrisville, NC, US
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042226221. Last updated year: 2026. Please use registration number 3042226221 when referencing this establishment in official correspondence.